[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539383":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":47,"centralContacts":51,"locations":61,"responsibleParty":101,"collaborators":105,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":111,"acronym":56,"eligibilityCriteria":112,"healthyVolunteers":109,"sex":113,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":56,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":125,"overallStatus":63,"whyStopped":56,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"Texas Tech University Health Sciences Center","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"One-dose group","EXPERIMENTAL","Patients assigned to this group will receive a liquid placebo followed by full-dose liquid amoxicillin 250mg PO thirty minutes later.",[13,14],"Drug: Amoxicillin 250 MG","Drug: Placebo",{"label":16,"type":17,"description":18,"interventionNames":19},"Graded, two-dose group","ACTIVE_COMPARATOR","Patients assigned to this group will receive liquid amoxicillin (25% of 250mg dose), followed by liquid amoxicillin 187.5mg PO (75% of 250mg dose) thirty minutes later.",[20,21],"Drug: Amoxicillin 62.5mg","Drug: Amoxicillin 187.5mg",[23,29,35,41],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Amoxicillin 250 MG","Liquid amoxicillin 250mg PO",[9],[9],{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Placebo","Given prior to amoxicillin 250mg in one-dose group",[9],[34],"Liquid placebo (Syrpalta or similar) for one-dose group",{"type":24,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Amoxicillin 62.5mg","Given first in two-dose group, liquid amoxicillin 62.5mg PO",[16],[40],"Two-dose group, dose 1 of 2",{"type":24,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"Amoxicillin 187.5mg","Given second in two-dose group, liquid amoxicillin 187.5mg PO",[16],[46],"Two-dose group, dose 2 of 2",[48],{"name":49,"affiliation":5,"role":50},"James A Tarbox, MD","PRINCIPAL_INVESTIGATOR",[52,58],{"name":53,"role":54,"phone":55,"phoneExt":56,"email":57},"Study Coordinator","CONTACT","806-543-8994",null,"clinicalresearch@ttuhsc.edu",{"name":59,"role":54,"phone":56,"phoneExt":56,"email":60},"Joshua A Peterson, MD","josh.peterson.587@gmail.com",[62],{"facility":5,"status":63,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"RECRUITING","Lubbock","Texas","79430","United States","US",{"type":70,"coordinates":71},"Point",[72,73],-101.85517,33.57786,{"lat":73,"lon":72},[76,77,78,80,82,84,86,88,89,91,93,95,97,99],{"name":53,"role":54,"phone":55,"phoneExt":56,"email":57},{"name":59,"role":54,"phone":56,"phoneExt":56,"email":60},{"name":59,"role":79,"phone":56,"phoneExt":56,"email":56},"SUB_INVESTIGATOR",{"name":81,"role":79,"phone":56,"phoneExt":56,"email":56},"Nicole Welch, MD",{"name":83,"role":79,"phone":56,"phoneExt":56,"email":56},"KaKa L Adams, MD",{"name":85,"role":79,"phone":56,"phoneExt":56,"email":56},"Sierra Sullivan, MD",{"name":87,"role":50,"phone":56,"phoneExt":56,"email":56},"Jacob Nichols, MD",{"name":49,"role":50,"phone":56,"phoneExt":56,"email":56},{"name":90,"role":79,"phone":56,"phoneExt":56,"email":56},"Watsachon Pangkanon, MD",{"name":92,"role":79,"phone":56,"phoneExt":56,"email":56},"Nattanicha Chaisrimaneepan, MD",{"name":94,"role":79,"phone":56,"phoneExt":56,"email":56},"Safa Mohamed, MD",{"name":96,"role":79,"phone":56,"phoneExt":56,"email":56},"Maireigh McCullough, MD",{"name":98,"role":79,"phone":56,"phoneExt":56,"email":56},"Diego Olavarria Bernal, MD",{"name":100,"role":79,"phone":56,"phoneExt":56,"email":56},"Miriam Paz Sierra, MD",{"type":102,"investigatorFullName":103,"investigatorTitle":104,"investigatorAffiliation":5,"oldNameTitle":56,"oldOrganization":56},"SPONSOR_INVESTIGATOR","James Tarbox, MD","Associate Professor",[106],{"name":5,"class":6},"100539383","phase-3-penicillin-allergy-delabeling-after-a-one-dose-versus-two-dose-graded-direct-oral-challenge-100539383",false,"NCT06303128","Penicillin Allergy Delabeling After a One-Dose Versus Two-Dose Graded Direct Oral Challenge","Inclusion Criteria:\n\n* Expresses interest in participating by calling or filling out information form on study website\n* Reports an allergy to one of the following medications: penicillin VK, penicillin G, amoxicillin, ampicillin, dicloxacillin, flucloxacillin, nafcillin, oxacillin, amoxicillin- clavulanate, ampicillin-sulbactam. Subjects with an unspecified penicillin allergy are also eligible to participate.\n\nExclusion Criteria:\n\n* Penicillin allergy deemed to be more than \"low-risk\" per PEN-FAST (score ≥ 3 points)\n* History of acute kidney injury (acute interstitial nephritis), severe liver impairment (drug- induced liver injury), serum sickness, or isolated drug fever attributed to a penicillin- based antibiotic\n* Anaphylaxis for any reason in the last year\n* Cognitive impairment where a collateral history could not be obtained and\u002For patient does not have capacity to consent for themselves\n* Pregnant (self-reported)\n* Any illness or condition that would increase the risk of participation in the study, per the evaluating clinician's judgment\n* Active treatment of or history of acute angle closure glaucoma\n* On H1- or H2-blockers (i.e. diphenhydramine, hydroxyzine, chlorpheniramine, cetirizine, levocetirizine, loratadine, fexofenadine or famotidine, ranitidine, cimetidine, nizatidine, respectively) within 72 hours of initiating direct oral challenge (will be counseled to discontinue prior to testing)\n* Actively receiving greater than stress dose steroid (hydrocortisone \\>50mg four times a day or steroid equivalent)\n* Actively receiving any antibiotic\n* Relative contraindication: Patients on beta blockers and angiotensin converting enzyme inhibitors (ACE inhibitors) will have an open dialog with the study team regarding the risks and benefits of testing a low-risk penicillin allergy patient. A joint decision will be made based on the patient's preference and the physician's comfort level.","ALL","18 Years","89 Years",{"count":117,"type":118},380,"ESTIMATED","INTERVENTIONAL",[121],"PHASE3","The goal of this clinical trial is to learn about dosing when testing to see if a penicillin allergy label can be removed from adults that had been labeled as \"penicillin-allergic\" previously. The main question it aims to answer is:\n\n\\- In penicillin-allergic patients that are at low risk of having an allergic reaction, is a one-dose oral challenge with amoxicillin (a penicillin-based antibiotic) as safe and effective as a two-dose oral challenge?\n\nParticipants will, after being identified as having a low-risk penicillin allergy, be administered oral amoxicillin in a controlled setting and then monitored for an allergic reaction. Researchers will compare participants that took one dose of amoxicillin to participants that took two doses of amoxicillin (a small dose and then a larger dose) to see if either group was more likely to develop an allergic reaction.",[124],"Penicillin Allergy",[126,127,128,129],"low-risk allergy","amoxicillin","drug allergy","direct oral challenge","2025-04-28",{"date":132,"type":133},"2025-05-01","ACTUAL",{"date":135,"type":133},"2024-02-03",{"date":137,"type":118},"2026-12",{"name":103,"class":6},1]